1 Duke University School of Medicine, Durham, NC, USA.
2 University of Pittsburgh, Pittsburgh, PA, USA.
Clin Trials. 2019 Jun;16(3):263-272. doi: 10.1177/1740774519829695. Epub 2019 Feb 19.
BACKGROUND/AIMS: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes.
A total of 214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient-caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient's death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain.
This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death.
The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.
背景/目的:疼痛是晚期癌症患者及其照顾者的主要关注点。有强有力的证据表明,基于认知行为原则的疼痛应对技能培训干预措施可以减轻疼痛的严重程度和干扰程度。然而,很少有此类干预措施针对晚期癌症患者及其家庭照顾者进行测试。本研究旨在测试以照顾者为指导的疼痛应对技能培训方案对患者和照顾者结局的疗效。
共纳入 214 名年龄≥18 岁、患有 III 期-IV 期癌症且疼痛程度为中度至重度的患者及其家庭照顾者,将其按 1:1 比例随机分配至照顾者指导的疼痛应对技能培训干预组或增强的常规治疗组。两组均接受疼痛管理方面的教育资源,照顾者指导的疼痛应对技能培训干预包括与患者-照顾者二人组进行三次每周 60 分钟的视频会议。在基线和干预后收集照顾者结局(帮助患者管理疼痛的自我效能感、照顾者负担、照顾满意度、心理困扰)和患者结局(疼痛管理的自我效能感、疼痛强度和干扰、心理困扰)的测量结果。在患者死亡后 3 个月和 6 个月时也会收集照顾者结局的测量结果。该研究正在从四家三级保健学术医疗中心和一家独立的临终关怀和姑息治疗组织招募患者。主要结局指标是照顾者帮助患者管理疼痛的自我效能感。
本文描述了 CaringPals 试验设计和实施中的挑战。试验设计的关键问题包括识别和招募患有晚期癌症和疼痛的患者,以及在患者死亡后对照顾者进行随访和收集数据。
CaringPals 试验通过满足晚期癌症患者及其照顾者的独特需求,解决了疼痛应对技能培训干预方面的研究空白。该研究的结果可能会推动晚期癌症和疼痛患者的临床护理进展,并更好地了解培训家庭照顾者帮助患者应对疼痛的效果。